Jobs at Heartflow

Lead the strategy, execution, oversight, and continuous improvement of Heartflow’s global Quality Management System. Manage CAPA, document control, training, audits, management reviews, tool validation, and supplier management. Serve as the QMS subject matter expert during FDA, Notified Body, and other regulatory audits. Lead and develop a quality team, promote a quality-first culture, drive KPI-based decisions, and collaborate with R&D, Production, Regulatory, Clinical, and Product Management teams to support compliant global expansion.

Lead software quality and design excellence for AI/ML-enabled medical devices and SaMD. Oversee design controls, QMS integration, risk management, software verification and validation, Design History Files, design transfer, regulatory submissions, and audit readiness. Advise on architecture, cybersecurity, privacy, Agile compliance, and validation frameworks for cloud infrastructure and AI/ML. Serve as a global quality subject matter expert while mentoring engineering, product, and program teams.

Lead software quality and design control for SaMD and AI/ML-enabled digital health products. Manage end-to-end SDLC design controls, risk analyses (HA, FTA, FMEA), and software V&V. Ensure regulatory compliance (IEC, ISO, AAMI), maintain audit-ready DHF, support global submissions (FDA, PMDA, EU-MDR), and coach R&D on quality and compliance within an Agile SaaS environment.